SLIDE 1
EAC MRH Programme 12 DEC 2019 GOAL To improve access to safe, - - PowerPoint PPT Presentation
EAC MRH Programme 12 DEC 2019 GOAL To improve access to safe, - - PowerPoint PPT Presentation
EAC MRH Programme 12 DEC 2019 GOAL To improve access to safe, efficacious and good quality essential medicines for the treatment of diseases of economic importance within EAC region and beyond. MRH PARTNERS WHO &SWISSMEDIC Technical
SLIDE 2
SLIDE 3
MRH PARTNERS
WHO &SWISSMEDIC Technical Assistance (TA) to EAC Secretariat and Partner States NMRAs NEPAD Advocacy and political commitment in enactment of relevant policies and regulatory framework WORLD BANK Financial Management and oversight for the MRH Grant BMGF- Provides Financial Support PARTNER STATES
SLIDE 4
MRH MRH MA MA
- Harmonized
technical guidelines developed- 2012- 2014
- Approved in Sep, 2019 by EAC
Council of Ministers
- 2015
Adoption and domestication by EAC Partner States
- 1st EOI for MA issued in Nov,
2015 - reproductive health products included
Harmonization process
SLIDE 5
Joi Joint t as assessment
Process Flow chart including timelines
SLIDE 6
JA A PROGRESS SS
- Total applications: 106
- Total assessed: 101
- Total recommended: 50
- Queried: 53
- Under
evaluation: 7
(Distributed to Assessors)
- Approved through MAGHP-4
Recommended Queried under evaluation Approved through MAGHP
SLIDE 7
EAC-SWISSMEDIC COLLABORATION
- Revision of existing
harmonized guidelines on MER and GMP-2018
- Participation of
swissmedic and WHO experts in JA sessions -for clinical and quality review
- f dossiers
- Training of EAC experts
- n MER and GMP
- Training on case/project
management
SLIDE 8
MA MAGH GHP
Global-
- EAC is a member and participates at ICH and
ICDRA ( International Conference of Drug Regulatory Authorities) meetings
- EAC experts participates in WHO PQ assessment
procedure Regional
- Developed abridged guidelines to guide on the
assessment of products already approved through WHO PQ collaborative procedure to fast tract and reduce registration timeline- within 90 days
- Convene joint dossier assessment sessions -13
sessions
- Coordinates approval and registration of
recommended medical products
- Capacity building of PS experts -participate in
the WHO PQ program
EAC Engagement
SLIDE 9
MA MAGH GHP
Global
- Participate in WHO PQ process
Regional and national
- Domestication of harmonized
guidelines
- Participation in EAC-MRH joint medical
product assessment and Good Manufacturing Practice Inspections
- Registration of the approved products
- Monitoring of Safety and quality of
products granted MA
- Sharing of skills, experience, knowledge
and expertise through twinning programs
PS Engagement
SLIDE 10
CON ONCLUSI SION
- WHO and Swiss medic-
Technical Expertise
- EAC Experts-Technical
expertise/capacity building
- PS- Commitment / Financial
and technical Support
- EAC Sec-
Staffing/Commitment, coordination/technical expertise/ capacity building
- Partners- financial/ Technical
Commitment
Access of medicines is a collaborative process that require harmonized efforts
SLIDE 11